ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Geodon in Weight Loss Study for Bipolar Disorders

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Stanford University
Pfizer
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00472641
  Purpose

This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.


Condition Intervention
Bipolar Disorder
Drug: Geodon (Ziprasidone)

MedlinePlus related topics:   Bipolar Disorder    Obesity   

Drug Information available for:   Ziprasidone    Ziprasidone hydrochloride    Ziprasidone mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:   Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.

Secondary Outcome Measures:
  • Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI) using a random regression mixed effects model, and the rate of change of weight and BMI.

Estimated Enrollment:   25
Study Start Date:   January 2007

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:Patients will meet the following criteria to be eligible to participate in the study:

  • Diagnosis of Bipolar Disorder Type I, Type II, or NOS treated in ongoing therapy with atypical antipsychotic(s) and/or mood stabilizer(s) that have been implicated in causing weight gain (i.e. lithium, valproate, olanzapine, risperidone, quetiapine, aripiprazole).
  • Age 18-65 years old
  • Males; or nonpregnant, nonlactating females who are postmenopausal, surgically sterilized, or using a barrier method of contraception and have a negative pregnancy test
  • Initial body mass index e 30 kg/m2, or e 27 kg/m2 and demonstrating or receiving treatment for metabolic consequences of overweight (fasting total cholesterol e 200mg/dL, fasting triglycerides e 250 mg/dL, or fasting blood glucose e 100 mg/dL).
  • Stable medication regimen of at least one month
  • Not have been hospitalized due to medical or psychiatric reasons during the past year from date of consent.
  • Ability to understand and cooperate with study procedures
  • Have signed a written informed consent prior to entering the study Exclusion Criteria:Patients may not participate in the study if they have any of the following conditions:
  • One of the following DSM-IV Axis I diagnoses: delirium, dementia, amnestic and other cognitive disorders, schizophrenia, anorexia nervosa or bulimia, or substance abuse or dependence (active within the last month), abuse of illicit drugs (excluding marijuana) within the past month
  • Antisocial personality disorder
  • Medical complications of obesity such as diabetes, hypertension, hyperlipidemia, and cardiovascular disease unless followed by their own general medical practitioner who authorizes their participation in the trial, and continues to follow them medically and make necessary adjustments of concurrent antidiabetic, antihypertensive, antihyperlipidemic agents during the trial;
  • Item 10 (Suicidal Thoughts) on the MADRS greater than or equal to 4
  • Suicide attempt within the past three months
  • Obesity of endocrine origin
  • Seizure disorders
  • Progressive neurologic or systemic disorders; HIV
  • Other serious illnesses such as cardiac, hepatic (including cirrhosis), renal, respiratory, neurologic, or hematologic disease or glaucoma
  • Hypothyroidism or hyperthyroidism unless adequately treated with TSH no more than 10% above or below the limits of the normal range.
  • Administration of any investigational drug within 30 days prior to screening
  • Allergy or hypersensitivity to ziprasidone
  • Administration of clozapine in the prior three months
  • Pregnancy within the past six months
  • Patients will be discontinued from the study should they develop any significant adverse side effects that cannot be managed by dosage adjustment
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472641

Locations
United States, California
Stanford University School of Medicine    
      Stanford, California, United States, 94305

Sponsors and Collaborators
Stanford University
Pfizer

Investigators
Principal Investigator:     Terence Arthur Ketter     Stanford University    
  More Information


Stanford University Bipolar Disorders Clinic  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   96972
First Received:   May 11, 2007
Last Updated:   March 6, 2008
ClinicalTrials.gov Identifier:   NCT00472641
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Body Weight
Obesity
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Bipolar Disorder
Weight Loss
Mood Disorders
Psychotic Disorders
Overweight
Ziprasidone
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers